REAL-WORLD DATA OF TENOFOVIR ALAFENAMIDE IN TREATMENT-NAIVE AND EXPERIENCED PATIENTS WITH CHRONIC HEPATITIS B: MORE EFFICACY, LESS SIDE EFFECTS


Bektaş E., Yılmaz A., Kıkılı C. İ., Nurıyev K., İstemihan Z., Şenkal İ. V., ...Daha Fazla

AASLD Liver Meeting , District Of Columbia, Amerika Birleşik Devletleri, 4 - 08 Kasım 2022, cilt.76, ss.299

  • Yayın Türü: Bildiri / Özet Bildiri
  • Cilt numarası: 76
  • Doi Numarası: 10.1002/hep.32697
  • Basıldığı Şehir: District Of Columbia
  • Basıldığı Ülke: Amerika Birleşik Devletleri
  • Sayfa Sayıları: ss.299
  • İstanbul Üniversitesi Adresli: Evet

Özet

Background:  Tenofovir  alafenamide  (TAF)  has  fewer  safety concerns and similar antiviral efficacy compared to  entecavir  (ETV)  and  tenofovir  disoproxil  fumarate  (TDF)  in  chronic  hepatitis  B  (CHB).  We  aim  to  pres-ent  efficacy  and  safety  data  of  TAF  in  the  real-world  patients. Methods:  This  is  a  retrospective  study  of  patients  (aged  above  18  years)  with  CHB  (HBeAg  +/-)  who have used TAF for at least 6 months. Longitudinal virological  and  biochemical  tests  were  performed  at  intervals.  HBV  DNA  level  <31.6  IU/mL  for  virological response,  serum  phosphorus  (Pi)  level  <2.5  mg/dl  for  hypophosphatemia, eGFR <60 mL/min/1.73m2 for azotemia, ALT level <35 in men and <25 IU/mL in women as  normalization  were  accepted. 

Results:  225  patients  were  included  in  this  study  [age  57  years  (IQR  48-65) , male 158 (70.2%), follow-up period 22 months (IQR   12-30),   cirrhotic   43   (19.1%),   decompensated   25/43  (58.1%),  72  post-liver  transplant,  41  prophylaxis  against reactivation]. 39 patients were treatment naive, 186  patients  were  switched  to  TAF  from  various  anti-virals  [TDF  164  (88%),  ETV  18  (10%),  others  4  (2%)].  Hypophosphatemia,  azotemia  and  ostoporosis  were  the  most  common  causes  (67%)  of  switching  to  TAF.  The  viral  load  of  anti-  viral  naive  patients  was  sup-pressed significantly (p=0.011) and virologic response improved significantly in switch to TAF group (p=0.003) (fig1).  HBsAg  loss  did  not  occur  in  any  patient.  eGFR  levels  before  and  after  TAF  treatment  did  not  change  significantly  in  total  group  unlike  low  baseline  eGFR  level  group,  eGFR  levels  increased  significantly  6-12  months after TAF (p<0.001). After 6-12 months of TAF therapy,  phosphorus  levels  improved  significantly  in  both  the  total  group  and  the  low  phosphorus  group  (p<0.001,  fig1).  Renal  toxicity  did  not  occur  in  naive  group. LDL and triglyceride levels did not change sig-nificantly in the total group after TAF treatment. 33 pa-tients had abnormal ALT levels in switch to TAF group, 29 of them have normalized after treatment. There was no need to give up treatment due to adverse reactions.

Conclusion: TAF has a potent viral suppressive effect in treatment-naive and experienced patients with CHB. Patients switched to TAF have improved renal function (characterized  by  elevated  eGFR  and  Pi  levels).  TAF  provided ALT normalization of patients and did not af-fect their lipid profiles. In CHB patients, TAF was safe, well-tolerated and effective in this real-world cohort.